Hepatocellular carcinoma
Conditions
Interventions
Microwave ablation
Radio frequency ablation
Sponsors
Tokyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with hepatocellular carcinomas (HCCs) which shows typical pattern on HCC by contrast-enhanced CT or MRI, and those of which are up to 4 lesions, each smaller than 4 cm 2. Patients who do not have radiologically extrahepatic metastases and gross vascular invasions 3. Presence or absence of pretreatment is not essential qualification; but it is necessary that at least more than 4 weeks has passed since previous treatment 4. Patients with Child-Pugh score less than or equal to 9 5. Patients who are considered to be curatively performed both MWA and RFA 6. Patients with ECOG performance status of 0 to 2 7. Patients preserved adequate bone morrow, liver and kidney functions, as shown below: White blood cell: more than or equal to 2,000 /mm3, and/or less than or equal to 10,000 /mm3 Platelet: more than or equal to 50,000 /mm3 Hemoglobin: more than or equal to 8.0 g/dL Serum total bilirubin: less than or equal to 2.0 mg/dL Prothrombin time: more than or equal to 50% Serum creatine: less than or equal to 1.5 mg/dL BUN: less than or equal to 35 mg/dL 8. More than or equal to 20-year-old, male and female 9. Patients who have obtained agreements for participation in writing
Exclusion criteria
Exclusion criteria: 1. Patients who have active double cancer (synchronous double cancer) or who have metachronous double cancer within five years disease duration: note that carcinoma in situ which is judged to be cure is not included 2. Patients who have diagnosed as myocardial infarction, unstable angina, cardiac failure, and arrhythmia with care within 6 months before registration 3. Patients who have either interstitial pneumonia, pulmonary fibrosis, and emphysema which is thought to be difficult to undergo this trial 4. Patients who have iodine allergies, decline in renal function (serum creatinine>1.5 mg/dL), and cannot undertake contrast-enhanced CT or MRI for any reasons 5. Patients who are judged to be difficult to undergo this clinical trial due to psychiatric disease or psychological symptom 6. Patients who are in pregnancy or probable of pregnancy 7. Besides, patients who are judged as inappropriate for registration by doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR) rate after 2-year from treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time, Recurrent-free survival time, Posttreatment 1-, 2-,3-year liver function, Recurrent pattern, Liver function at recurrent time, Severe adverse events rate | — |
Countries
Japan
Contacts
Public ContactKatsutoshi Sugimoto
Tokyo Medical University Dept. of Gastroenterology and Hepatology
Outcome results
None listed